A panel of respiratory experts voted in favor of approving an experimental inhaler drug from GlaxoSmithKline and Theravance for treating chronic lung disease. A majority of panelists felt that the Breo Ellipta inhaler is safe and effective for long-term use and to control flare ups in patients with COPD.
Acura Pharmaceuticals Inc. benefited greatly from a decision by federal regulators to block new painkillers that aren't designed to resist abuse. The company sells a decongestant called Nexafed and its abuse-deterring technology is used in Pfizer Inc.'s painkiller Oxecta.
Researchers have identified a molecule that prevents repair of some cancer cells, providing a potential new "genetic chemotherapy" approach to cancer treatment that could significantly reduce side effects and the development of treatment resistance compared with traditional chemotherapy.
Allergan Inc. said that the Food and Drug Administration isn't ready to approve its inhaled migraine treatment Levadex. Allergan said the FDA is concerned about elements of the manufacturing process for Levadex. The company said it is already responding to those concerns.
Federal health regulators will require generic versions of the best-selling painkiller OxyContin to include recent formulation changes designed to make the pill harder to abuse. The Food and Drug Administration said it would not approve any generic versions of OxyContin based on the original formulation.
Stem cells and tissue-specific cells can be grown in abundance from mature mammalian cells simply by blocking a certain membrane protein. Experiments show that the process doesn’t require other kinds of cells or agents to artificially support cell growth and doesn’t activate cancer genes.
The Justice Department said Amgen paid kickbacks to Omnicare Inc. and PharMerica Corp., which sell drugs to long-term care providers like nursing homes and hospitals, and Kindred Healthcare Inc., which runs long-term acute care hospitals and nursing and rehabilitation centers.
Actavis is once again selling a generic version of Bayer's oral contraceptive Yaz because a federal appeals court overturned one of the patents supporting the original. The company began selling it in January 2012, but took the drug off the market after a federal court in Nevada upheld the patent.
Researchers have discovered that rising temperature induces key changes in the dengue virus when it enters its human host, and the findings represent a new approach for designing vaccines against the aggressive mosquito-borne pathogen.
Eli Lilly and Company announced positive top-line results of two additional Phase 3 AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 receptor agonist being studied as a once-weekly treatment for type 2 diabetes.
Johnson & Johnson's first-quarter profit fell by just over 10% as increased sales were offset by higher costs for production, marketing, and administration. The maker of Tylenol, prescription drugs, and medical devices said that it earned $3.5 billion, down 10.6%, from $3.9 billion a year earlier.
The Food and Drug Administration has posted its review of Theravance and partner GlaxoSmithKline's combination inhaler drug to treat lung disease. The companies have asked the FDA to approve their experimental inhaler drug, Breo Ellipta, to treat complications of chronic lung disease.
Thermo Fisher Scientific Inc. has offered to pay about $13.6 billion to buy genetic testing equipment maker Life Technologies in a cash deal that will create a giant company serving research and specialty diagnostics. Life Technologies Corp. shareholders and regulators still need to approve the acquisition.
Abbott Laboratories is recalling its FreeStyle InsuLinx Blood Glucose Meters after finding that they display and store incorrect test results for dangerously high blood sugar levels. Johnson & Johnson announced a similar recall last month for several types of its blood glucose meters.
Researchers have succeeded in transforming skin cells directly into oligodendrocyte precursor cells, the cells that wrap nerve cells in the insulating myelin sheaths that help nerve signals propagate. If the approach also works with human cells, it could eventually lead to cell therapies for MS and paralysis.